FDA product code MPI: Glenoid Fossa Prosthesis
MPI is the FDA product code for glenoid fossa prosthesis. It is a Class III device, regulated under 21 CFR 872.3950 and reviewed by the Dental panel. Devices under MPI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Glenoid Fossa Prosthesis |
| Device class | Class III |
| Regulation | 21 CFR 872.3950 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MPI devices
openFDA lists no recalls for product code MPI.
Frequently asked questions
What is FDA product code MPI?
MPI is the FDA product code for glenoid fossa prosthesis. It is a Class III device, regulated under 21 CFR 872.3950 and reviewed by the Dental panel.
What device class is MPI?
Class III, regulation 21 CFR 872.3950. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MPI
- Run a recall and safety report across every MPI manufacturer
- Watch product code MPI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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